Requirements for manufacturing cosmetic products
Manufacturers of cosmetic products are required to submit a Statement of Compliance to the Spanish Agency of Medicines and Medical Devices (AEMPS).
The manufacturer is required to list all the activities for which it is responsible in this document, including its own activities and subcontracted work. This statement demonstrates that the manufacturer produces products in accordance with Good Manufacturing Practices and minimum manufacturing standards. Proper management of the Statement of Compliance requires clarity on what information should be declared, when the document should be submitted to the agency, and who is responsible for the activities.
Regulation (EC) No 1223/2009 outlines the obligations of Responsible Persons and distributors, both of which share certain obligations, such as notifying the health authorities if a product is believed to present a risk to health and cooperating with the health authorities. However, whereas Article 5 stipulates that the Responsible Person must comply in general with Articles 3 to 24, Article 6 states that the distributor must comply with Article 19. Therefore, Responsible Persons clearly have more obligations than distributors.
In addition, Regulation (EC) No 1223/2009 states that cosmetic products must be manufactured in accordance with Good Manufacturing Practices (GMPs).
This regulation stipulates that manufacturers must adhere to the UNE-EN ISO 22716 standard on Good Manufacturing Practices. Therefore, it is highly recommended to have this certification.
A good understanding and management of the UNE-EN ISO 22716 standard will provide guidelines for the production, control, storage, and dispatch of cosmetic products. This translates into good management of the human, technical and administrative factors that ultimately affect product quality by ensuring that products are manufactured in a consistent and controlled manner in compliance with regulations while also minimising production risks.
Good manufacturing practice includes the layout of the factory. Manufacturing flow, personnel flow, and goods movement should all be considered according to these guidelines. Taking these three points into account will help to prevent cross-contamination, which occurs when a product comes into contact with undesirable substances, such as dust from raw material containers. The main design principles should always aim to protect the product, facilitate cleaning and minimise the risk of cross-contamination.
The type of product being manufactured should also be considered, and materials that are non-toxic, durable and easy to clean should be used in the manufacturing process.
There are also areas inside the factory with special requirements, including production areas and quality control laboratories. Finally, the entire premises should be located on a suitable site that is stable, uncontaminated, and equipped with some form of pest control.
Azierta’s experts in cosmetic products can provide personalised advice on your products, answer any questions you may have and help to guarantee the success of your project. Contact us!